Study Evaluating Subjects With Distal Renal Tubular Acidosis
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ClinicalTrials.gov Identifier: NCT03644706 |
Recruitment Status :
Not yet recruiting
First Posted : August 23, 2018
Last Update Posted : June 21, 2021
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Condition or disease | Intervention/treatment | Phase |
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Distal Renal Tubular Acidosis | Drug: ADV7103 Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | A Phase 3 Multicenter, Randomized, Double-Blinded, Placebo-Controlled Withdrawal Study Evaluating ADV7103 In Pediatric and Adult Subjects With Distal Renal Tubular Acidosis (dRTA) |
Estimated Study Start Date : | June 2021 |
Estimated Primary Completion Date : | April 2022 |
Estimated Study Completion Date : | August 2022 |

Arm | Intervention/treatment |
---|---|
Active Comparator: ADV7103
Patients continue to receive ADV7103 twice a day at their open label dose over 6 days
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Drug: ADV7103
Each dose of ADV7103 contains a fixed ratio of 1/3 of ADV7103-CK (potassium citrate) and 2/3 of ADV7103-BK (potassium bicarbonate) based on the mass of active substances. The strength is 6.44 (± 10 %) mEq/g of ADV7103 (alkalinizing power).
Other Name: Potassium Citrate and Potassium Bicarbonate |
Placebo Comparator: Placebo Comparator
Patients receive matched placebo twice a day until they reach a bicarbonate level of 18mEq/L
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Drug: Placebo
Placebo is a combination of 2 mm green coated lactose granules and 2 mm white coated lactose granules. Each dose of placebo contains a fixed ratio of 1/3 of green granules and 2/3 of white granules. |
- Mean change in blood bicarbonate levels [ Time Frame: 6 days ]Compare the efficacy of ADV7103 versus placebo in preventing metabolic acidosis, defined as 2 consecutive serum bicarbonate levels < 18 mEq/L for subjects ≥ 4 years old and < 17 mEq/L for subjects < 4 years old, during the Withdrawal Period

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Ages Eligible for Study: | 6 Months to 65 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Female or male subjects ≥ 6 months of age and ≤ 65 years of age at time of consent;
- Subject presents with a previous diagnosis of primary dRTA of at least 4 months duration for subjects < 12 years of age, and at least one year for those ≥ 12 years of age, based on documented history of non-anion gap, hyperchloremic, hypokalemic metabolic acidosis;
- Subject requires ≥ 0.9 mEq/kg/day of alkali therapy to maintain serum bicarbonate levels above the LLN for the laboratory providing results;
Exclusion Criteria:
- Female subject who is pregnant or lactating or has plans for pregnancy during the study;
- Subject has evidence of proximal tubule dysfunction (eg, hypophosphatemia, low serum uric acid, glycosuria, or amino aciduria);
- Subject presents with another diagnosed condition as a potential etiology for her/his dRTA (eg, systemic lupus erythematosus, Sjogren's syndrome), in the opinion of the Investigator;
- Subject requires therapy with potassium sparing diuretics, angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, trimethoprim, drospirenone and other progestins, nephrotoxic antibiotics, penicillins, tacrolimus, or medications known to delay gastric emptying or otherwise interfere with absorption of study product;
- Subject has evidence of obstructive uropathy or other findings on renal ultrasound associated with Visit 1 expected to require intervention during the course of the study, in the opinion of the Investigator;
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Subject has any of the following laboratory abnormalities associated with Visit 1:
- AST and/or ALT > 1.5x upper limit of normal (ULN)
- Serum potassium > 5.0 mEq/L or <3.0 mEq/L or hypokalemia accompanied by clinical symptoms (eg, muscle cramps) or significant ECG changes (eg T wave depression, U wave elevation)
- Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 (according to the updated Schwartz formula for children and Chronic Kidney Disease - Epidemiology Collaboration [CKD-EPI] formula for adults)
- Total bilirubin > ULN, except with known Gilbert's disease.
- Subject has been hospitalized or had outpatient surgery (other than minor skin and dRTA disease-related procedures or ear tube placement) in the past 6 months or is planning surgery in the next 6 months;

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03644706
United States, California | |
University of California | |
San Francisco, California, United States, 94158 | |
United States, Colorado | |
Children's Hospital Colorado | |
Aurora, Colorado, United States, 80045 | |
United States, Connecticut | |
Connecticut Children's Hospital | |
Hartford, Connecticut, United States, 06106 | |
United States, Florida | |
University of South Florida Pediatric Infectious Disease | |
Tampa, Florida, United States, 33606 | |
United States, Georgia | |
Emory Children's Center | |
Atlanta, Georgia, United States, 30322 | |
United States, Indiana | |
J.W. Riley Hospital for Children | |
Indianapolis, Indiana, United States, 46202 | |
United States, Missouri | |
Washington University/St. Louis Children's Hospital | |
Saint Louis, Missouri, United States, 63110 | |
United States, New York | |
Montefiore Medical Center | |
Bronx, New York, United States, 10467 | |
United States, Pennsylvania | |
The Children's Hospital of Philadelphia | |
Philadelphia, Pennsylvania, United States, 19104 | |
Canada, Alberta | |
University of Alberta | |
Edmonton, Alberta, Canada, T6G 2R3 | |
Canada, Ontario | |
The Hospital for Sick Children | |
Toronto, Ontario, Canada, M5G 1X8 | |
Canada, Quebec | |
The Research Institute of the McGill University Health Centre | |
Montreal, Quebec, Canada, H4A 3J1 |
Study Chair: | Andre Ulmann, MD, Ph.D. | Advicenne Pharma |
Responsible Party: | Advicenne Pharma |
ClinicalTrials.gov Identifier: | NCT03644706 |
Other Study ID Numbers: |
B23CS |
First Posted: | August 23, 2018 Key Record Dates |
Last Update Posted: | June 21, 2021 |
Last Verified: | June 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Acidosis, Renal Tubular Acidosis Acid-Base Imbalance Metabolic Diseases Renal Tubular Transport, Inborn Errors Kidney Diseases Urologic Diseases |
Genetic Diseases, Inborn Potassium Citrate Diuretics Natriuretic Agents Physiological Effects of Drugs Expectorants Respiratory System Agents |